(313 days)
Not Found
No
The summary describes a composite resin material and its physical properties, with no mention of AI or ML.
No
The device is a dental restorative material (flowable composite resin) used for restorations, not a device intended to treat or cure a disease or medical condition.
No
Explanation: The device is described as a light-cured flowable composite resin used for restorations, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "light-cured flowable composite resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are "Base/liner" and "Pit & Fissure sealant." These are procedures performed directly on the patient's tooth, not tests performed on samples taken from the body.
- Device Description: The device is a "light-cured flowable composite resin" used for "anterior and posterior composite restorations." This describes a material used for dental fillings and sealants, which are therapeutic or restorative procedures.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose. IVDs are designed to diagnose diseases or conditions based on the analysis of such samples.
Therefore, this device falls under the category of a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Base/liner
- Pit & Fissure sealant
Product codes
EBF, EBC
Device Description
Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human tooth, Dentin, Enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing on the proposed Bright High Flow has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed: Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), Sensitization (ISO 10993-10), Acute systemic toxicity (ISO 10993-11), Genotoxicity (ISO 10993-3), Implantation (ISO 10993-6), Chronic toxicity (ISO 10993-11). All tests passed.
The proposed Bright High Flow was evaluated using the following performance bench testing to confirm the performance characteristics: Visual (ISO 4049), Capacity (ISO 4049), Package (ISO 4049), Sensitivity to Ambient Light (ISO 4049), Depth of Cure (ISO 4049), Shade (ISO 4049), Color Stability (ISO 4049), Flexural Strength (ISO 4049), Water Sorption (ISO 4049), Solubility (ISO 4049), Radio-opacity (ISO 4049). All tests passed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.
November 30, 2020
GENOSS Co., Ltd. Hong Jeon Manager 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si, 16229 KOREA
Re: K200155
Trade/Device Name: Bright High Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: October 22, 2020 Received: October 22, 2020
Dear Hong Jeon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.
Indication for use
510(k) Number: K200155
Device Name: Bright High Flow
Indication for use:
-
Base/liner
-
Pit & Fissure sealant
Prescription Use __ V__ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indication for use
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Image /page/3/Picture/1 description: The image shows the word "GENOSS" in green font. The first three letters, "GEN", are in a darker green, while the last three letters, "OSS", are in a lighter green. The letters are all capitalized and have a bold appearance. The word appears to be a logo or brand name.
510(k) Summary
12/20/2019
1. Company
| Submitter | |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 |
| Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea | |
| Phone/Fax | +82-70-7098-7541/ +82-31-888-5105 |
| Contact person | HongJun Jeon / RA |
| hjjeon@genoss.com | |
| Summary Date | 12/20/2019 |
2. Device Name
Proprietary name: Bright High Flow Regulation description : Light-cured Flowable Composite Resin Classification name: Tooth shade resin material
3. Predicate Device
K091388 G-aenial Universal Flo
4. Description
Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is bold and sans-serif, with the letters connected to each other.
5. Indication for use
-
- Base/liner
-
- Pit & Fissure sealant
6. Technological Characteristics
Bright High Flow has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of Bright High Flow, Gaenial Universal Flo are as following.
| Device name | Bright High Flow | G-aenial Universal Flo | |
|---|---|---|---|
| Manufacturer | Genoss Co., Ltd. | GC America, Inc. | |
| 510(k) Number | New Device | K091388 | |
| Clinical | Target population | Human tooth | Human tooth |
| Purpose | Direct restoration | Direct restoration | |
| Site of application | Dentin, Enamel | Dentin, Enamel | |
| Clinical Performance | High flexural strength and strong bonding | High flexural strength and strong bonding | |
| Biological | Materials | Methacrylate resins, Fillers | |
| (Barium glass, Silica) | Methacrylate resins, Fillers | ||
| (Barium glass, Silica) | |||
| Chemical Safety | Biocompatible | Biocompatible | |
| Sterilization | Non-sterile | Non-sterile | |
| Shelf-Life | 2 years | 3 years | |
| Technical | Form | Paste | Paste |
| Indication for use | 1) Base / liner |
- Pit & Fissure sealant | 1) Direct restorative for Class I, IV, III,
II and V cavities. - Fissure sealant
- Sealing hypersensitive areas
- Repair of (in) direct aesthetic
restorations, temporary crown &
bridge, defect margins when margins |
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Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters are connected and have a rounded, modern look.
| | | are in enamel
5) Blocking out undercuts
6) Liner or base |
|-------------------|---------------------------------------------------------------|----------------------------------------------------------------|
| Use | Prescription | Prescription |
| Depth of cure | ISO 4049:2009 7.10 (More than 1.5 mm) | |
| Water Sorption | ISO 4049:2009 7.12 (Less than 40 $\mu g/mm^3$ ) | |
| Solubility | ISO 4049:2009 7.12 (Less than 7.5 $\mu g/mm^3$ ) | |
| Flexural Strength | ISO 4049:2009 7.11 (More than 80 MPa) | |
| Radio-opacity | ISO 4049:2009 7.14 (More than the same thickness of aluminum) | |
7. Performance Data
Biocompatibility testing on the proposed Bright High Flow has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:
(P: Pass, F: Fail)
| No. | Test | Method | Acceptance criteria | P/F | Report No. |
|---|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | None cytotoxicity | P | CDM-18-0061- |
| 12 | |||||
| 2 | Irritation | ISO 10993-10 | None oral irritation | P | MTK-2018- |
| 000707 | |||||
| 3 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2018- |
| 000706 | |||||
| 4 | Acute systemic | ||||
| toxicity | ISO 10993-11 | None systemic | |||
| toxicity | P | MTK-2018- | |||
| 000706 | |||||
| 5 | Genotoxocity | ISO 10993-3 | None genotoxicity | P | MTK-2018- |
| 000705 |
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Image /page/6/Picture/0 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The logo has a modern and clean design.
| 6 | Implantation | ISO 10993-6 | Biocompatible | P | BER-18-028 |
|---|---|---|---|---|---|
| 7 | Chronic toxicity | ISO 10993-11 | No chronic toxicity | P | BER-18-028 |
The proposed Bright High Flow was evaluated using the following performance bench testing to confirm the performance characteristics:
| No. | Items | Method | Acceptance Criteria | P/F | File No. |
|---|---|---|---|---|---|
| 1 | Visual | ISO 4049 | No impurities and No specific changes | P | CDM-18-0061-01 |
| 2 | Capacity | ISO 4049 | Capacity error of; Standard Capacity $\lt \pm 5%$ | P | CDM-18-0061-02 |
| 3 | Package | ISO 4049 | No damage | P | CDM-18-0061-03 |
| 4 | Sensitivity to Ambient Light | ISO 4049 | Must be physically uniform | P | CDM-18-0061-04 |
| 5 | Depth of Cure | ISO 4049 | More than 1.5 mm | P | CDM-18-0061-05 |
| 6 | Shade | ISO 4049 | Must be shade uniform | P | CDM-18-0061-06 |
| 7 | Color Stability | ISO 4049 | Color should be stable | P | CDM-18-0061-07 |
| 8 | Flexural Strength | ISO 4049 | More than 80 MPa | P | CDM-18-0061-08 |
| 9 | Water Sorption | ISO 4049 | Less than 40 $\mu g/mm^3$ | P | CDM-18-0061-09 |
| 10 | Solubility | ISO 4049 | Less than 7.5 $\mu g/mm^3$ | P | CDM-18-0061-10 |
| 11 | Radio-opacity | ISO 4049 | More than Al | P | CDM-18-0061-11 |
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Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright High Flow met the established specifications necessary for consistent performance according to its intended use.
8. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that Bright High Flow is acceptable and safe, substantially equivalent to predicate devices.